Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-472-3 | CAS number: 141-24-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 March 1999 -4 APril 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methyl ricinoleate
- EC Number:
- 205-472-3
- EC Name:
- Methyl ricinoleate
- Cas Number:
- 141-24-2
- Molecular formula:
- C19H36O3
- IUPAC Name:
- methyl ricinoleate
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animais
Sex, species, strain: male New Zealand White rabbits.
Reason for this choice: species generally accepted by regulatory authorities for this type of study. Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number of animais: three animais were used, as recommended by the international guidelines. Identification: the animais were identified individually with a metal ear tag.
Weight: on the day of treatment, the animais had a mean body weight ± standard deviation of 2.5 ± 0.2 kg.
Acclimatization: at least 5 days before the beginning of the study.
Environmental conditions
The conditions in the animal room were set as follows:
.temperature: 18 ± 3°C
. relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. ln addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
The animais were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle.
Food and water
During the study, the animais had free access to 112 C pelleted diet (UAR, 91360 Villemoisson sur-Orge, France).
Each batch of food was analysed by the supplier for composition and contaminant levels. The diet formula is presented in appendix 2.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are performed regularly by extemal laboratories.
The results of these analyses are archived at CIT.
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- A single dose of 0.1 ml of the test substance was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
- Observation period (in vivo):
- The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test substance.
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- The study design was established according to available information on the test substance and the above guidelines.
As possible irritant effects were anticipated, the test substance was administered to a single male New Zealand White rabbit, in the first instance.
Since the test substance was not irritant for this first animal, it was administered to two other male New Zealand White rabbits.
A single dose of 0.1 ml of the test undiluted substance was instilled into the left conjunctival sac. The right eye was not treated and served as control.
The eyes were not rinsed after administration of the test substance.
Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration.
The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and comeal opacity were calculated for each animal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean 3 r
- Remarks:
- rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: mean 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0 - 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: mean 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
lndividual ocular examinations and mean values of the scoresrecorded at each reading (24,48and72hours) for each animal
Rabbit Region Description Scores Mean Interpretationnumber ofeye ofocular irritation (+)
reactions lh 24h 48h 72h score(1) (-)
Dl 02 03 04
716 |
Conjunctivae |
Chemosis |
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Redness |
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Discharge |
E |
0 |
0 |
0 |
0.0 |
|
|
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
Comealopacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Arca |
0 |
0 |
0 |
0 |
0.0 |
|
|
OtherFluorescein |
|
* I |
*u |
* I |
* I |
|
|
717 |
Conjunctivae |
Chemosis |
2 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Redness |
2 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Discharge |
E |
0 |
0 |
0 |
0.0 |
|
|
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
Comealopacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Arca |
0 |
0 |
0 |
0 |
0.0 |
|
|
OtherFluorescein |
|
"' I |
"' u |
"' I |
"' I |
|
|
718 |
Conjunctivae |
Chemosis |
1 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Redness |
1 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Discharge |
E |
0 |
0 |
0 |
0.0 |
|
|
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
Comealopacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
(-) |
|
|
Arca |
0 |
0 |
0 |
0 |
0.0 |
|
|
OtherFluorescein |
|
* I |
"' u |
"' I |
"' |
|
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Non irritating
- Executive summary:
The study design was established according to available information on the test substance and the above guidelines.
A single dose of 0.1ml of the test undiluted substance was instilled into the left conjunctival sac.The right eye was not treated and served as control.
The eyes were not rinsed after administration of the test substance.
Ocular reactions were observed approximately 1hour, 24, 48 and 72 hours after the administration.
The mean values of the scores for chemosis, redness of the conjunctiva,iris lesions and comeal opacity were calculated for each animal.
Results
Very slight reactions were observed in two animals on day 1 only; No other ocular reactions were observed during the study.
Mean scores alculated for eachanimal over 24,48 and 72hours were 0.0,0.0 and 0.0 for chemosis, 0, 0, 0, 0 and 0 for redness and 0 for iris lesions and 0 for corneal opacity.
Conclusion
Under our experimental conditions, the test substance RICINOLEATE DE METHYLE (batch No.9802001) is non-irritant when administered by ocular route to rabbits.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.